{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T06:33:29Z","timestamp":1777876409672,"version":"3.51.4"},"reference-count":28,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Sandoz\/HEXAL AG"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Med Oncol"],"published-print":{"date-parts":[[2018,1,1]]},"abstract":"<jats:p>\n                    Patent expirations for several biological products have prompted the development of alternative versions, termed \u2018biosimilars\u2019, which have comparable quality, safety and efficacy to a licensed biological medicine (also referred to as the \u2018reference\u2019 medicine). The first biosimilars developed in oncology were the supportive-care agents filgrastim and epoetin. Binocrit\n                    <jats:sup>\u00ae<\/jats:sup>\n                    (HX575) is a biosimilar version of epoetin alfa, indicated in the oncology setting for the treatment of chemotherapy-induced anemia (CIA). The process for development and approval of Binocrit\n                    <jats:sup>\u00ae<\/jats:sup>\n                    as a biosimilar included extensive analytical characterization and comparison with the reference epoetin alfa. This was followed by a clinical development program comprising phase I pharmacokinetic\/pharmacodynamic studies to show bioequivalence to the reference medicine and a confirmatory phase III study to confirm therapeutic effectiveness in CIA. Since its approval, Binocrit\n                    <jats:sup>\u00ae<\/jats:sup>\n                    has been extensively used and studied in real-world clinical practice. The accumulated data confirm that Binocrit\n                    <jats:sup>\u00ae<\/jats:sup>\n                    is an effective and well-tolerated option for the treatment of CIA in patients with cancer.\n                  <\/jats:p>","DOI":"10.1177\/1758835918768419","type":"journal-article","created":{"date-parts":[[2018,4,17]],"date-time":"2018-04-17T06:37:18Z","timestamp":1523947038000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["Development and 10-year history of a biosimilar: the example of Binocrit\n                    <sup>\u00ae<\/sup>"],"prefix":"10.1177","volume":"10","author":[{"given":"Matti","family":"Aapro","sequence":"first","affiliation":[{"name":"Cancer Center, Clinique de Genolier, Genolier, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andriy","family":"Krendyukov","sequence":"additional","affiliation":[{"name":"Sandoz Biopharmaceuticals, HEXAL AG, Industriestr. 25, D-83607 Holzkirchen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nadja","family":"H\u00f6bel","sequence":"additional","affiliation":[{"name":"Biostatistics, Sandoz Biopharmaceuticals, Oberhaching, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Seidl","sequence":"additional","affiliation":[{"name":"Technical Development Biosimilars, HEXAL AG, Oberhaching, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pere","family":"Gasc\u00f3n","sequence":"additional","affiliation":[{"name":"Department of Hematology-Oncology, Hospital Cl\u00ednic de Barcelona, University of Barcelona, Barcelona, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2018,4,17]]},"reference":[{"key":"bibr1-1758835918768419","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.01770214"},{"key":"bibr2-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1136\/esmoopen-2016-000142"},{"key":"bibr3-1758835918768419","volume-title":"Delivering on the potential of biosimilar medicines","author":"IMS Institute for Health Informatics","year":"2016"},{"key":"bibr4-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.343"},{"key":"bibr5-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1517\/14712598.2016.1128410"},{"key":"bibr6-1758835918768419","unstructured":"European Medicines Agency. 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Scientific guidelines on biosimilar medicinal products. http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/regulation\/general\/general_content_000408.jsp (2017, accessed 16 November 2017)."},{"key":"bibr10-1758835918768419","unstructured":"Eprex Summary of Product Characteristics. https:\/\/www.medicines.org.uk\/emc\/medicine\/20282 (2017, accessed 16 November 2017)."},{"key":"bibr11-1758835918768419","first-page":"34","volume":"15","author":"Brockmeyer C","year":"2009","journal-title":"EJHP Practice"},{"key":"bibr12-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(16)30374-6"},{"key":"bibr13-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1038\/nbt0110-28"},{"key":"bibr14-1758835918768419","unstructured":"European Medicines Agency. Binocrit, INN-epoetin alfa: scientific discussion. European Medicines Agency, http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Scientific_Discussion\/human\/000725\/WC500053615.pdf (2007, accessed 9 February 2018)."},{"key":"bibr15-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6904-9-10"},{"key":"bibr16-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1159\/000189027"},{"key":"bibr17-1758835918768419","first-page":"168","volume":"32","author":"Weigang-K\u00f6hler K","year":"2009","journal-title":"Onkologie"},{"key":"bibr18-1758835918768419","doi-asserted-by":"publisher","DOI":"10.2217\/fon.12.39"},{"key":"bibr19-1758835918768419","first-page":"43","volume":"5","author":"Rodriguez Garzotto A","year":"2014","journal-title":"J Blood Med"},{"key":"bibr20-1758835918768419","volume-title":"Poster presented at the European Cancer Congress","author":"Metges J-P"},{"key":"bibr21-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1177\/1758834016670554"},{"key":"bibr22-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V122.21.3430.3430"},{"key":"bibr23-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1002\/hon.2412"},{"key":"bibr24-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1007\/s00277-017-2950-9"},{"key":"bibr25-1758835918768419","first-page":"380","volume":"72","author":"Haag-Weber M","year":"2009","journal-title":"Clin Nephrol"},{"key":"bibr26-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1007\/s00277-014-2070-8"},{"key":"bibr27-1758835918768419","doi-asserted-by":"publisher","DOI":"10.2165\/11588270-000000000-00000"},{"key":"bibr28-1758835918768419","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.2012.712681"}],"container-title":["Therapeutic Advances in Medical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1758835918768419","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1758835918768419","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1758835918768419","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T22:22:19Z","timestamp":1777587739000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1758835918768419"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,1,1]]},"references-count":28,"alternative-id":["10.1177\/1758835918768419"],"URL":"https:\/\/doi.org\/10.1177\/1758835918768419","relation":{},"ISSN":["1758-8359","1758-8359"],"issn-type":[{"value":"1758-8359","type":"print"},{"value":"1758-8359","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,1,1]]},"article-number":"1758835918768419"}}